Thursday, March 15, 2012
March 15, 2012 GA Mesh News
Many folks are seeing the term "POP" when they hear about mesh and mesh implants failing. Pelvic Organ Prolapse is commonly called POP - P is the condition that results when the normal supporting structures of the vagina deteriorate.
The resultant support loss can cause any or all of the following structures to prolapse (drop out of
position): urethra, bladder, bowel, and/or cervix/ uterus/ vaginal vault. This prolapse can produce
such symptoms as a sensation of bulge, difficulty with bowel or bladder function, pain and/ or
dyspareunia (painful intercourse). Traditional treatment options for POP include hysterectomy,
colporrhaphy (plication of pubocervical or rectovaginal fascia), sacro-colpopexy (suturing of
vaginal apex to the sacral promontory using either mesh or fascial bridge) performed either
abdominally or laparoscopically and sacrospinous fixation (securing the vaginal apex to the
sacrospinous ligament). Mesh products were introduced as supporting materials in the surgical
treatment of POP to address the high levels of recurrence rates associated with traditional repairs
using the patient’s own tissue,.
In July 2011, the Food and Drug Administration (FDA) issued an updated safety notification
concerning the safety and effectiveness of transvaginal surgical mesh devices for POP repair and
a White Paper titled, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of
Transvaginal Placement for Pelvic Organ Prolapse.
While the 2011 notification references similar kinds of complications as had been reported in FDA’s 2008 notification, FDA changed its prior assessment of the frequency of adverse events (AEs) associated with these devices, and identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
Based on its updated assessment, FDA is considering changes to the regulation of transvaginal
mesh products, such as reclassification from Class II to Class III or additional pre-market and
post-market regulatory requirements.
Read more on the FDA site: http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf